Biopharm has launched an updated tool to help biotherapeutics manufacturers compare the costs of different process development “recipes.” Biosolve Process 5 predicts the cost of scaling up development and will show users which of their facilities a new technology best fits, Biopharm’s CEO told BioPharma-Reporter.com.
Users can model processes involving mAbs (monoclonal antibodies), vaccines, cell therapy products, microbial therapeutics, antibody drug conjugates and fill-finish operations.
Neglected: process development
Cost modelling is increasingly sought in biotherapeutics manufacture, especially in the early stages and for chronic therapies, said Andrew Sinclair, Biopharm CEO, previously Head of Logistics at Lonza.
“In biotechnology, not a lot of thought has been given to manufacturing requirements in process development.” Instead the industry has historically concentrated on “getting the science right.”
But as biologics have matured into a multibillion dollar industry, it is becoming more important to build an understanding of manufacturing and process costs, “especially as drugs move from acute to chronic indications, and as new medicines roll out to the developing world.”
Assessing cost is important right from the beginning, as the early stage of process development is where there are the most opportunities to drive down cost, said the CEO. “As you move along the development pathway into Phase III, your scope for changing technology is limited. At that point you’ve fixed your dosing regime. For these complex molecules you don’t want to change the process too much in case it changes molecule as you get near to launch.”
Sinclair gave the example of small biotechnology company Promedior, which had used BioSolve to generate cost scenarios comparing different expression systems: CHO (Chinese hamster ovary) cells, microbial and natural source human plasma.
The results – which recommended genetically engineering the protein into different microorganisms – won the company a financial benefit of “orders of magnitude,” said Sinclair.
For the newest therapeutic proteins which treat chronic conditions such as asthma, the cost of treatment becomes even more important, said Sinclair, because patients will take the drugs for long periods of time.
One area that BioSolve frequently reveals as ripe for cost savings is switching to continuous bioprocessing, said Sinclair.
While all the technology needed for a completely continuous manufacturing line does not yet exist, equipment that allows 24/7 manufacturing is “gaining a lot of traction” he said.
Non-stop processing can cut costs for biologics makers because it allows smaller machinery, he said. “In large scale manufacturing plants a bioreactor size is 20,000L; that defines the batch. But in continuous manufacture, because you’re working 24/7, the whole scale reduces – the machinery is physically a lot smaller and much more manageable. So facility costs come right down. And flexibility goes up because the scale is so much smaller.”
As well as reactors, perfusion and chromatography technology are biomanufacturing areas that are moving into continuous technology, said Sinclair.
The software service is sold on an annual subscription bases, or as a one-off for occasional projects. As well as process innovators, the tool also attracts suppliers who want to understand the impact of their technology on clients’ processes, said the CEO. Past versions of the software have been used by MedImmune, Merck & Co. and Sartorius, he said.